NCT02385370

Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method

Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced glaucoma that are candidates for trabeculectomy will be included. Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	MMC	using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
DRUG	MMC	0.1 cc of 0.01% MMC is injected into the tenon.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-12-01
• First posted: 2015-03-11
• Last updated: 2015-03-11

Locations

1 site across 1 country: Iran